Prescription drug · ANDA

Chlorpromazine Hydrochloride NDC 50268-164

Chlorpromazine hydrochloride 50 mg/1 · Tablet, Film coated · Oral · AvPAK

NDC codes

FDA NDC Directory
Product NDC (as listed)50268-164Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50268-0164Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
50268-164-15502680164155026801641550 BLISTER PACK in 1 BOX (50268-164-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-164-11)Marketed from Feb 14, 2020

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Chlorpromazine Hydrochloride
Generic name (nonproprietary)
chlorpromazine hydrochloride
Active ingredients
Chlorpromazine hydrochloride — 50 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
AvPAKNDC labeler code 50268
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209755
Marketing start
Listing expires
Other FDA classes
Phenothiazines (Chemical structure)
Identifiers
Product ID 50268-164_47e24518-b486-ad20-e063-6294a90ad040SPL ID 47e24518-b486-ad20-e063-6294a90ad040SPL set ID 9e8cebc0-7fcf-dca8-e053-2a95a90a3369RxCUI 991039, 991044, 991188, 991194, 991336UNII 9WP59609J6
Pharmacologic class
Phenothiazine

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N450268016415 followed by a unit qualifier and the quantity

Package 50268-0164-15. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanyi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50268-164

What is NDC 50268-164?
50268-164 is the product NDC for Chlorpromazine Hydrochloride, Chlorpromazine hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by AvPAK. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Chlorpromazine Hydrochloride.
What is the active ingredient?
Chlorpromazine hydrochloride.
Who is the labeler?
AvPAK, NDC labeler code 50268. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Chlorpromazine Hydrochloride?
106 other product NDCs are listed under this name. See all Chlorpromazine Hydrochloride NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Chlorpromazine Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Chlorpromazine HydrochlorideChlorpromazine hydrochloride 25 mg/1Tablet, Sugar coatedOralAmerican Health Packaging60687-93860687-0938-0160687-0938-65
Chlorpromazine HydrochlorideChlorpromazine hydrochloride 50 mg/1Tablet, Sugar coatedOralAmerican Health Packaging60687-94960687-0949-01
Chlorpromazine HydrochlorideChlorpromazine hydrochloride 100 mg/1Tablet, Sugar coatedOralAmerican Health Packaging60687-96060687-0960-01
Chlorpromazine HydrochlorideChlorpromazine hydrochloride 200 mg/1Tablet, Sugar coatedOralAmerican Health Packaging60687-97160687-0971-01
Chlorpromazine HydrochlorideChlorpromazine hydrochloride 100 mg/mLConcentrateOralSaptalis Pharmaceuticals, LLC.71656-10171656-0101-08
Chlorpromazine HydrochlorideChlorpromazine hydrochloride 30 mg/mLConcentrateOralSaptalis Pharmaceuticals, LLC.71656-10271656-0102-04
Chlorpromazine HydrochlorideChlorpromazine hydrochloride 25 mg/mLInjectionIntramuscularNovadoz Pharmaceuticals LLC72205-19072205-0190-25
Chlorpromazine HydrochlorideChlorpromazine hydrochloride 25 mg/mLInjectionIntramuscularNovadoz Pharmaceuticals LLC72205-19172205-0191-25
Chlorpromazine HydrochlorideChlorpromazine hydrochloride 25 mg/1Tablet, Sugar coatedOralCoupler LLC67046-163367046-1633-03
chlorpromazine hydrochlorideChlorpromazine hydrochloride 30 mg/mLConcentrateOralAdvagen Pharma Ltd72888-45772888-0457-01

All 107 Chlorpromazine Hydrochloride NDCs

Other NDCs under ANDA 209755

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 209755
ProductStrengthForm · routeLabelerProduct NDC
Chlorpromazine HydrochlorideChlorpromazine hydrochloride 25 mg/1Tablet, Film coatedOralAmneal Pharmaceuticals NY LLC69238-1056
Chlorpromazine HydrochlorideChlorpromazine hydrochloride 50 mg/1Tablet, Film coatedOralAmneal Pharmaceuticals NY LLC69238-1058
Chlorpromazine HydrochlorideChlorpromazine hydrochloride 200 mg/1Tablet, Film coatedOralAmneal Pharmaceuticals NY LLC69238-1062
Chlorpromazine HydrochlorideChlorpromazine hydrochloride 100 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-452
Chlorpromazine HydrochlorideChlorpromazine hydrochloride 100 mg/1Tablet, Film coatedOralAmneal Pharmaceuticals NY LLC69238-1060
Chlorpromazine HydrochlorideChlorpromazine hydrochloride 200 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-463
Chlorpromazine HydrochlorideChlorpromazine hydrochloride 10 mg/1Tablet, Film coatedOralAvPAK50268-162
Chlorpromazine HydrochlorideChlorpromazine hydrochloride 200 mg/1Tablet, Film coatedOralAvPAK50268-166
Chlorpromazine HydrochlorideChlorpromazine hydrochloride 25 mg/1Tablet, Film coatedOralAvPAK50268-163
Chlorpromazine HydrochlorideChlorpromazine hydrochloride 100 mg/1Tablet, Film coatedOralAvPAK50268-165
Chlorpromazine HydrochlorideChlorpromazine hydrochloride 10 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-419
Chlorpromazine HydrochlorideChlorpromazine hydrochloride 25 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-430
Chlorpromazine HydrochlorideChlorpromazine hydrochloride 50 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-441
Chlorpromazine HydrochlorideChlorpromazine hydrochloride 10 mg/1Tablet, Film coatedOralAmneal Pharmaceuticals NY LLC69238-1054

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